Matoride XL Tablet Prolonged Release 36mg

Država: Malta

Jezik: engleski

Izvor: Malta Medicines Authority

Aktivni sastojci:

METHYLPHENIDATE HYDROCHLORIDE

Dostupno od:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC koda:

N06BA04

INN (International ime):

METHYLPHENIDATE HYDROCHLORIDE 36 mg

Farmaceutski oblik:

PROLONGED-RELEASE TABLET

Sastav:

METHYLPHENIDATE HYDROCHLORIDE 36 mg

Tip recepta:

POM

Područje terapije:

PSYCHOANALEPTICS

Status autorizacije:

Withdrawn

Datum autorizacije:

2014-11-12

Uputa o lijeku

Page 1 of 10
1.3.1.3 PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MATORIDE XL, 18 MG, PROLONGED-RELEASE TABLETS
MATORIDE XL, 36 MG, PROLONGED-RELEASE TABLETS
MATORIDE XL, 54 MG, PROLONGED-RELEASE TABLETS
methylphenidate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Matoride XL is and what it is used for
2.
What you need to know before you take Matoride XL
3.
How to take Matoride XL
4.
Possible side effects
5.
How to store Matoride XL
6.
Contents of the pack and other information
1. WHAT MATORIDE XL IS AND WHAT IT IS USED FOR_ _
WHAT IT IS USED FOR
Methylphenidate is used to treat ‘Attention Deficit Hyperactivity
Disorder’ (ADHD).

It is used in children, young people between the ages of 6 and 18.

It is used only after trying treatments which do not involve
medicines. Such as counselling and
behavioural therapy.
Methylphenidate is not for use as a treatment for ADHD in children
under 6 years of age or in
adults. When treatment was started at a younger age, it might be
appropriate to continue taking
Matoride XL when you become an adult. Your doctor will advise you
about this.
HOW IT WORKS
Methylphenidate improves the activity of certain parts of the brain
which are underactive. The
medicine can help improve attention (attention span), concentration
and reduce impulsive
behaviour.
The medicine is given as part of a treatment programme, which usually
includes:

psychological

educational and

social therapy
It is prescribed only by doctors who have ex

Svojstava lijeka

Page 1 of 21
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Matoride XL
, 18 mg, prolonged-release tablets
Matoride XL
, 36 mg, prolonged-release tablets
Matoride XL
, 54 mg, prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Matoride XL
18 mg, prolonged-release tablets:
Each tablet contains 18 mg of methylphenidate hydrochloride.
Excipient(s) with known effect: contains 6.31 mg of lactose
monohydrate.
Matoride XL
, 36 mg, prolonged-release tablets:
Each tablet contains 36 mg of methylphenidate hydrochloride.
Excipient(s) with known effect: contains 8.43 mg of lactose
monohydrate.
Matoride XL
, 54 mg, prolonged-release tablets:
Each tablet contains 54 mg of methylphenidate hydrochloride.
Excipient(s) with known effect: contains 6.76 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Matoride XL
, 18 mg, prolonged-release tablets:
Light yellow film-coated tablet of round shape (diameter 8 mm) with a
delivery orifice (visible round small
hole) on one side.
Matoride XL
, 36 mg, prolonged-release tablets:
White film-coated tablet of round shape (diameter 10 mm) with a
delivery orifice (visible round small hole)
on one side.
Matoride XL
, 54 mg, prolonged-release tablets:
Red film-coated tablet of round shape (diameter 10 mm) with a delivery
orifice (visible round small hole) on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Page 2 of 21
Attention-Deficit/Hyperactivity Disorder (ADHD)
Methylphenidate prolonged-release tablets is indicated as part of a
comprehensive treatment programme for
Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6
years of age and over when remedial
measures alone prove insufficient. Treatment must be under the
supervision of a specialist in childhood
behavioural disorders. Diagnosis should be made according to DSM 5
criteria or the guidelines in ICD-10
and should be based on a complete history and evaluation of the
patient. Diagnosis cannot